Yoga Based Psychotherapy Group Feasibility and Efficacy Study
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 12 |
| Updated: | 4/17/2018 |
| Start Date: | January 2009 |
| End Date: | August 23, 2017 |
This preliminary study will examine the feasibility of conducting a randomized clinical trial
of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared
to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma).
The goal of the study is to inform the method and sample size for a larger randomized trial
to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of
behavior, emotions, and daily functioning. Children who have experienced trauma, including
sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence,
parental substance abuse, mental health disorders, and incarceration are at risk to have
dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and
trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the
using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.
of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared
to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma).
The goal of the study is to inform the method and sample size for a larger randomized trial
to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of
behavior, emotions, and daily functioning. Children who have experienced trauma, including
sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence,
parental substance abuse, mental health disorders, and incarceration are at risk to have
dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and
trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the
using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.
One hundred fifty children (ages 8-12 years) treated at the Center for Child and Family
Traumatic Stress (CCTFS) for at least 3 months and their caregivers (total n=300 individuals)
will be eligible to be enrolled in this randomized preliminary study if CCTFS Clinician
identifies that the child is continuing to have difficulty with behavior and emotional
regulation. Children will be invited to participate in the study. Informed consent will be
obtained following explanation of the study. If the child meets both Stage 1 and 2 Screening
criteria,
Stage 1 Screening:
Child receives a T-score > 60 on any of the Child Behavior Checklist Parent Rating Scales,
and
Stage 2 Screening:
KKFC Psychiatric evaluation (Child Psychiatrist will be masked to study status). Child
Psychiatrist evaluation will determine whether medication is appropriate for the child and
whether the child/family environment is stable and safe. If the child is deemed appropriate
for psychotropic medications, other than stimulants, the child will not be eligible for the
study (due to the possible changes in one of the outcome measures, heart rate variability,
that will likely result from use of psychotropic medications that can not be stopped 24 hours
prior to study evaluation). [Children on stimulant medication will be asked to stop
medication one day prior to study evaluation and of the day of evaluation.]
The child will be randomized to Group 1: to continue Standard Care Mental Health (SCMH)
treatment or Group 2: Standard Mental Health and Yoga Based Psychotherapy Group.
Children with T-scores lower than 60 will continue in Standard Mental Health Treatment.
Recruitment will take place over three years.
A block randomization design (block size 4) will be used to ensure roughly equal distribution
of YBPG and SCMH patients over the enrollment time. An opaque bag with four colored marbles
(two red, two black) will be utilized for the randomization. The child, in the presence of
the parent, will be asked to select a colored marble out of the bag; the marbles will be
replaced after enrollment of sets of 4 children. Depending on the color of the marble the
child will be assigned to either YBPG or SCMH.
Children randomized to YBPG must be cleared by their pediatric care provider (Appendix 1).
Children in YBPG group will participate in YBPG as outlined in Appendix 2; participation
duration is expected to be 12 weeks. Parents in the YBPG group will participate in a
psychoeducational intervention to learn about YBPG and support the child's practice of YBPG.
Following 12 weeks of YBPG children will resume SCMH if necessary.
Children will be assessed following informed consent, at 3 months (following YBPG or 6 months
of SCMH), 6 months, and 12 months following randomization.
Assessments:
1. Baseline EKG and respiratory rate (RR) will be measured for 5 minutes. Heart rate
variability will be measured using a data collection system that will take EKG and
respiratory rate recordings for 5 minutes, and analyzed using the CardioBatch software
from the Brain Body Center of the University of Illinois. The Trier Social Stress Test
13 for children will be administered. The Trier consists of the research assistant
telling the child the beginning of a story and having the child complete the story in 5
minutes. Then the child is asked to perform math problems for 5 minutes. EKG and
respiratory rate (RR) will be re-measured for 10 minutes after the Trier.
2. Child Behavior Checklist (CBCL) 14;15. The CBCL is a written measure designed to assess
behavioral and emotional problems in children. There are several forms including a
version for children from 1 1/2 to 5 years and a version for children 6-18 years 14;15.
There are also Parent, Youth, and Teacher rating forms. The Youth Behavior Rating will
be used to obtain a self-report of the child's behavioral and emotional status. Each
version yields standard scores (Mean = 50, standard deviation = 10) to assess behavior
problems in several specific areas; these scores are also combined into three global
scores: an Internalizing score for emotional problems, an Externalizing score for
behavior problems, and a Total problem score. The Parent Questionnaire form of the CBCL
will be used. The CBCL is expected to take 20 minutes to complete.
3. Trauma Symptom Checklist for Young Children (TSCYC) and Trauma Symptom Checklist for
Children (TSCC) 16: The TSCYC is a 90-item parent report of children's symptoms
associated with traumatic events (e.g., child abuse, peer assaults, community violence).
The TSCYC is normed and standardized as a trauma measure for children ages three to 12
years and includes measurements of validity of parent report and norms for the number of
waking hours the parent spends with the child during an average week. The instrument
includes nine subscales, Post-traumatic Stress-Intrusion, Post-traumatic
Stress-Avoidance, Post-traumatic Stress-Arousal, Post-traumatic Stress-Total, Sexual
Concerns, Dissociation, Anxiety, Depression, and Anger/Aggression. The TSCYC is expected
to take 15-20 minutes to complete. Alpha values on a multi-site clinical sample of
traumatized children ranged from 0.81 for Sexual Concerns to 0.93 for Post-traumatic
Stress-Total17. The TSCC is a 54 item child questionnaire that has Anxiety, Depression,
Anger, Posttraumatic Stress, Dissociation, and Sexual Concerns. Alpha values range from
0.77 for Sexual Concerns to 0.89 for Anger. The TSCC is expected to take 10-15 minutes
to complete.
4. Behavior Emotional Rating Scale (BERS-2) 18: The BERS-2 is a 52-item Likert scale that
measures the children emotional and behaviors strengths through parent, child, and
observer report. The BERS-2 is designed for children ages 5 years to 18 years and is
divided into five subscales, namely, (1) Interpersonal Strengths, (2) Family
Involvement, (3) Intrapersonal Strengths, (4) School Functioning, and (5) Affective
Strengths. Teacher/Clinician, Parent, and Youth Rating Scales will be used in this grant
to assess child behavioral and emotional functioning. Cultural/ethnic normative sample
were representative of the United States population. Internal consistency ranges from
0.77 to 0.99. The BERS is expected to take 15 minutes to complete.
5. The University of California Los Angeles-Post Traumatic Stress Disorder (UCLA-PTSD) is
used to screen both for exposure to traumatic events and for DSM-IV PTSD symptoms in
children and adolescents who report traumatic experiences. The UCLA PTSD is expected to
take approximately 15 minutes.
6. The Ontario Child Neglect Index (CNI) is a clinician administered assessment designed to
identify types and severity of different forms of child neglect. It is designed for use
with families already identified by a child protective service agency. The CNI is a
6-scale index and utilizes a 4- to 5-level rating of severity (e.g., adequate,
inconsistent, inadequate, seriously inadequate). The score is interpreted as a severity
rating of neglect, rather than a binary (yes/no) neglect score. Scores can range from
0-80. The recommended cutoff score is 50. The CNI is expected to take approximately 5
minutes to complete.
7. Demographic information (e.g, gender, age, race/ethnicity, parental age, education,
employment, marital status, etc.) will be collected. In addition, medical information
including medications, psychiatric diagnosis, birth history, history of maltreatment and
psychosocial history will be obtained by parent interview or electronic record review.
Traumatic Stress (CCTFS) for at least 3 months and their caregivers (total n=300 individuals)
will be eligible to be enrolled in this randomized preliminary study if CCTFS Clinician
identifies that the child is continuing to have difficulty with behavior and emotional
regulation. Children will be invited to participate in the study. Informed consent will be
obtained following explanation of the study. If the child meets both Stage 1 and 2 Screening
criteria,
Stage 1 Screening:
Child receives a T-score > 60 on any of the Child Behavior Checklist Parent Rating Scales,
and
Stage 2 Screening:
KKFC Psychiatric evaluation (Child Psychiatrist will be masked to study status). Child
Psychiatrist evaluation will determine whether medication is appropriate for the child and
whether the child/family environment is stable and safe. If the child is deemed appropriate
for psychotropic medications, other than stimulants, the child will not be eligible for the
study (due to the possible changes in one of the outcome measures, heart rate variability,
that will likely result from use of psychotropic medications that can not be stopped 24 hours
prior to study evaluation). [Children on stimulant medication will be asked to stop
medication one day prior to study evaluation and of the day of evaluation.]
The child will be randomized to Group 1: to continue Standard Care Mental Health (SCMH)
treatment or Group 2: Standard Mental Health and Yoga Based Psychotherapy Group.
Children with T-scores lower than 60 will continue in Standard Mental Health Treatment.
Recruitment will take place over three years.
A block randomization design (block size 4) will be used to ensure roughly equal distribution
of YBPG and SCMH patients over the enrollment time. An opaque bag with four colored marbles
(two red, two black) will be utilized for the randomization. The child, in the presence of
the parent, will be asked to select a colored marble out of the bag; the marbles will be
replaced after enrollment of sets of 4 children. Depending on the color of the marble the
child will be assigned to either YBPG or SCMH.
Children randomized to YBPG must be cleared by their pediatric care provider (Appendix 1).
Children in YBPG group will participate in YBPG as outlined in Appendix 2; participation
duration is expected to be 12 weeks. Parents in the YBPG group will participate in a
psychoeducational intervention to learn about YBPG and support the child's practice of YBPG.
Following 12 weeks of YBPG children will resume SCMH if necessary.
Children will be assessed following informed consent, at 3 months (following YBPG or 6 months
of SCMH), 6 months, and 12 months following randomization.
Assessments:
1. Baseline EKG and respiratory rate (RR) will be measured for 5 minutes. Heart rate
variability will be measured using a data collection system that will take EKG and
respiratory rate recordings for 5 minutes, and analyzed using the CardioBatch software
from the Brain Body Center of the University of Illinois. The Trier Social Stress Test
13 for children will be administered. The Trier consists of the research assistant
telling the child the beginning of a story and having the child complete the story in 5
minutes. Then the child is asked to perform math problems for 5 minutes. EKG and
respiratory rate (RR) will be re-measured for 10 minutes after the Trier.
2. Child Behavior Checklist (CBCL) 14;15. The CBCL is a written measure designed to assess
behavioral and emotional problems in children. There are several forms including a
version for children from 1 1/2 to 5 years and a version for children 6-18 years 14;15.
There are also Parent, Youth, and Teacher rating forms. The Youth Behavior Rating will
be used to obtain a self-report of the child's behavioral and emotional status. Each
version yields standard scores (Mean = 50, standard deviation = 10) to assess behavior
problems in several specific areas; these scores are also combined into three global
scores: an Internalizing score for emotional problems, an Externalizing score for
behavior problems, and a Total problem score. The Parent Questionnaire form of the CBCL
will be used. The CBCL is expected to take 20 minutes to complete.
3. Trauma Symptom Checklist for Young Children (TSCYC) and Trauma Symptom Checklist for
Children (TSCC) 16: The TSCYC is a 90-item parent report of children's symptoms
associated with traumatic events (e.g., child abuse, peer assaults, community violence).
The TSCYC is normed and standardized as a trauma measure for children ages three to 12
years and includes measurements of validity of parent report and norms for the number of
waking hours the parent spends with the child during an average week. The instrument
includes nine subscales, Post-traumatic Stress-Intrusion, Post-traumatic
Stress-Avoidance, Post-traumatic Stress-Arousal, Post-traumatic Stress-Total, Sexual
Concerns, Dissociation, Anxiety, Depression, and Anger/Aggression. The TSCYC is expected
to take 15-20 minutes to complete. Alpha values on a multi-site clinical sample of
traumatized children ranged from 0.81 for Sexual Concerns to 0.93 for Post-traumatic
Stress-Total17. The TSCC is a 54 item child questionnaire that has Anxiety, Depression,
Anger, Posttraumatic Stress, Dissociation, and Sexual Concerns. Alpha values range from
0.77 for Sexual Concerns to 0.89 for Anger. The TSCC is expected to take 10-15 minutes
to complete.
4. Behavior Emotional Rating Scale (BERS-2) 18: The BERS-2 is a 52-item Likert scale that
measures the children emotional and behaviors strengths through parent, child, and
observer report. The BERS-2 is designed for children ages 5 years to 18 years and is
divided into five subscales, namely, (1) Interpersonal Strengths, (2) Family
Involvement, (3) Intrapersonal Strengths, (4) School Functioning, and (5) Affective
Strengths. Teacher/Clinician, Parent, and Youth Rating Scales will be used in this grant
to assess child behavioral and emotional functioning. Cultural/ethnic normative sample
were representative of the United States population. Internal consistency ranges from
0.77 to 0.99. The BERS is expected to take 15 minutes to complete.
5. The University of California Los Angeles-Post Traumatic Stress Disorder (UCLA-PTSD) is
used to screen both for exposure to traumatic events and for DSM-IV PTSD symptoms in
children and adolescents who report traumatic experiences. The UCLA PTSD is expected to
take approximately 15 minutes.
6. The Ontario Child Neglect Index (CNI) is a clinician administered assessment designed to
identify types and severity of different forms of child neglect. It is designed for use
with families already identified by a child protective service agency. The CNI is a
6-scale index and utilizes a 4- to 5-level rating of severity (e.g., adequate,
inconsistent, inadequate, seriously inadequate). The score is interpreted as a severity
rating of neglect, rather than a binary (yes/no) neglect score. Scores can range from
0-80. The recommended cutoff score is 50. The CNI is expected to take approximately 5
minutes to complete.
7. Demographic information (e.g, gender, age, race/ethnicity, parental age, education,
employment, marital status, etc.) will be collected. In addition, medical information
including medications, psychiatric diagnosis, birth history, history of maltreatment and
psychosocial history will be obtained by parent interview or electronic record review.
Inclusion criteria:
- Children, ages 8-12 years,
- enrolled in treatment at KKFC and their caregivers will be invited to participate if
the child continues to exhibit behavior dysregulation (Conners' Parent Rating
Scale-Revised (S) of > 60) following 3 months of SCMH at the KKFC.
- Children may have a history of receiving psychotropic medications or be currently
taking stimulants at the time of study enrollment.
Exclusion criteria:
- Children who are on psychotropic medications or medications that affect their heart
rates, other than stimulants will be excluded from this preliminary study.
- Children with cardiac arrhythmias, endocrine disorders associated with heart rate
irregularities or who are not able to cooperate or understand study procedures will be
excluded.
- Non-English speaking children will be excluded. Children in foster care placements
will be excluded.
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